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HCW/PRO – April 2012
PEER REVIEW LEVELS; REQUIREMENTS FOR PROJECTS
Level 1a
Minimum level of peer review required:
No peer review required
Projects in this category:
Studies that involve minimal risk to participants
Examples of projects or procedures in this category:
Short questionnaire studies for use among hospital staff or GPs
Questionnaires asking participants about the quality of hospital services, or requesting other
non-personal data, taking up to 10 minutes for a patient, or 20 minutes for a healthy
volunteer
Use of data from medical notes by clinician looking after patient
Examples of projects or procedures not included in this category:
Acquisition of new personal or laboratory data about patients
Lengthy questionnaires that represent a significant burden to the participant (e.g. taking more
than 10 minutes for a patient, or 20 minutes for a healthy volunteer)
Histological studies on existing/historical specimens
Questionnaires involving personal data
History taking
Non-intimate examination techniques, e.g. blood pressure measurement
Spirometry
Urinalysis
Level 1b
Minimum level of peer review required:
No peer review required
Projects in this category:
Studies that have been specifically peer reviewed by either:
i)a major grant-giving body or similar organisation. These include the following: UK Research
Councils (including the Medical Research Council); the National Institute for Health
Research; and Members of the Association of Medical Charities (including the Wellcome
Trust and a large number of specialist or disease-specific charities). This exemption does not
include projects that are part of a programme grant but which have not been specifically
considered by the grant-giving body. Applicants need to be able to demonstrate to the REC
and to the IC Joint Research Office that the relevant grant-giving body had conducted formal
peer review of the particular piece of research proposed.
or ii) a pharmacutical company that has initiated and designed the study. Investigator-led
projects that are merely supported by pharmaceutical or other external funding will
generally require review through the PRO.
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HCW/PRO – April 2012
Level 2
Minimum level of peer review required:
Departmental colleague or student project supervisor
Projects in this category:
Low-risk projects with minimal patient involvement
Student projects that involve either no patient/participant involvement or only minor involvement
Examples of projects or procedures in this category:
Routine history taking
Non-intimate physical examination e.g. joint examination, blood pressure measurement
Non-intimate photography or video recording (where the participant is neither recognizable
nor identifiable from the image)
Histological studies on existing/historical specimens
Projects using existing stored data
Administration of simple questionnaires that do not involve “sensitive” (e.g. psychiatric,
sexual, drug or end of life-related) information, unless that information is part of normal
clinical practice for the condition under study
Venesection involving a single skin puncture: up to 50mls from healthy volunteers, 20 mls
from patients (or pro rata for children)
Taking of blood via existing cannula or at same time as venesection which is part
of normal patient care: in single or multiple samples, total volumes as above
Spirometry
The obtaining or analysis of non-invasive samples, e.g. urine, saliva, faeces.
Examples of projects not included in this category:
Intimate physical examination
Histological studies on newly acquired specimens
Questionnaires involving “sensitive” (e.g. psychiatric, sexual, drug or end of life-related)
information that is outside normal clinical practice for the condition under study
Intimate photography or video recording
Taking of blood: more than 50mls from healthy volunteers and 20mls from
patients (pro rata for children)
Physiological experiments on students or healthy volunteers involving an element of risk e.g.
hypoxia.
Administration of drug or device to participants
Level 3
Minimum level of peer review required:
Individual within Imperial College or the applicant’s hospital trust
Projects in this category:
Projects with minor patient or participant risk
Examples of projects or procedures in this category:
Intimate physical examination, photography, or video recording when appropriate to clinical
context and where the participant is neither recognizable nor identifiable from the image
Taking of up to two blood samples of no more than 25mls each from healthy volunteers,
10mls from patients (or pro rata for children)
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HCW/PRO – April 2012
Taking of extra biopsies during biopsy procedure that is part of normal care
A minor lengthening of an invasive procedure (such as less than 5 minutes or 10% added
to a procedure that is part of patient care, whichever is the shorter), with little or no extra
risk associated with either the investigation or the lengthening of the procedure
Investigation that involves a minimal risk procedure (e.g. arterial blood gas analysis)
New acquisition of personal data that are not part of the normal clinical history
Projects working with genetic material researching a condition known to the patient
Administration of questionnaires involving “sensitive” information outside of normal
clinical practice
Single-arm study of a drug or device not affecting patient care decisions
Clinical intervention study or controlled trial with low risk to participants (e.g. a study of
an oral nutritional supplement, low vitamin doses, or dietary intervention)
Examples of projects or procedures not included in this category:
Intimate physical examination, photography, or video recording outside of appropriate clinical
context or where the participant is recognizable or identifiable from the image
Use of radiation
Research involving embryos
Projects with the potential for diagnosis of new genetic conditions
Randomized trials of drugs or devices within their licensed use
Withdrawal of existing/standard therapy
Level 4
Minimum level of peer review required:
Two reviewers, including one individual outside IC or the applicant’s hospital trust
Projects in this category:
Projects with greater than minor risk to participants
Examples of projects or procedures in this category
Phase I, II and III drug or device trials.
Randomized trials of drugs or devices within their licensed use
Intimate physical examination photography or video recording outside of appropriate clinical
context or where the participant is recognizable or identifiable from the image
Use of radiation
Research involving embryos
Projects with the potential for diagnosis of new genetic conditions
Additional Considerations
Vulnerable Adults
In the case of adults who are unable to give consent in situations where consent is deemed to be
appropriate, the project should receive review at one Level higher than the project is graded without
this condition.
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